Quality Inspector - $25/hr

Job Description

The Quality Inspector ensures that critical components, materials, and documentation meet established standards by performing detailed inspections and thorough manufacturing change order and document reviews. This role splits time between hands-on inspection activities and reviewing electronic and paper records within ERP, MES, and QMS systems to maintain product quality and compliance in a regulated manufacturing environment.

Responsibilities

• Perform inspections of incoming, in-process, and final components and materials, including hardware, cables, plastic consumables, gaskets, and other parts, to ensure they meet defined specifications.
• Inspect and release all assigned critical components in accordance with documented procedures and quality requirements.
• Conduct receiving inspections and manage inspection activities within ERP, MES, and QMS systems to maintain accurate records and traceability.
• Review and process manufacturing change orders and associated documentation, ensuring all changes are accurately captured and properly implemented.
• Carefully review electronic forms, paper documentation, engineering drawings, batch records, and other production documents for accuracy and completeness.
• Document all inspection activities clearly and accurately, including recording results, measurements, and observations in the appropriate electronic systems and spreadsheets.
• Identify conforming versus nonconforming parts, determine what passes or fails, and document nonconformances against requirements in a timely and precise manner.
• Support investigations into defective materials by providing detailed inspection data and participating in root cause analysis as needed.
• Assist Operations teams in prioritizing inspections to support continuous production flow and minimize delays.
• Perform material sorting to separate conforming parts from nonconforming parts based on inspection criteria and measurements.
• Use calipers, micrometers, CNC-related measurement outputs, and other precision measuring equipment to take accurate measurements and perform simple math and averaging of multiple readings.
• Conduct visual inspections, including using a microscope or Dyno-Lite scope periodically, to detect defects and verify component quality.
• Use Excel and other spreadsheet tools to record, analyze, and track inspection data, including entering measurements and maintaining logs.
• Work within an eQMS and eMES environment to execute inspection tasks, record results, and manage documentation in compliance with Good Documentation Practices (GDP).
• Coordinate with warehouse and supply chain teams to communicate inspection results, release decisions, and any issues affecting material availability.
• Collaborate closely with teammates to divide inspection work efficiently, follow templates and work instructions, and ensure key notes and requirements for each part are followed.
• Communicate effectively with cross-functional teams, including production, quality, and office staff, to resolve issues and support continuous improvement.
• Apply knowledge of regulated industry practices (such as medical device, aerospace, or biotech) to ensure compliance with applicable standards and procedures.
• Perform assigned inspection tasks as directed, while maintaining high levels of accuracy, attention to detail, and adherence to established procedures.
• Exercise sound judgment and analytical thinking when evaluating inspection results, determining nonconformance, and escalating issues.
• Support a fast-paced work environment by multitasking, adapting to changing priorities, and managing multiple inspection assignments.
• Follow basic Lean Six Sigma concepts when applicable to improve inspection processes and reduce waste.
• Maintain accessibility to the production floor, supply chain areas, and office staff as needed to carry out inspection duties and collaborate effectively.
• Adhere to physical requirements of the role, including sitting, standing, walking regularly, and occasionally lifting up to 25 pounds, while frequently using a computer and reading written documents.

Essential Skills

• Proven experience performing quality inspections, ideally within a medical device or other regulated manufacturing environment.
• Ability to identify conforming versus nonconforming parts and clearly determine what passes or fails based on requirements.
• Strong experience using calipers and other precision measuring tools; ability to perform simple math and averaging of multiple measurements.
• Hands-on experience with inspection tools and equipment such as calipers, micromete